DRUG
Heparin Sodium
Intravenous Heparin titrated to Partial ThromboplastinTime (PTT) levels
Status
Withdrawn
Phase
Phase 1
Enrollment
0
Locations
1
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
This is an open label, randomized study comparing the clinical outcomes of unfractionated Heparin and Bivalirudin for anticoagulation in adult subjects requiring ECMO support.
Full detailed description
This open label randomized study will compare the clinical outcomes of patients on ECMO who are anticoagulated with Heparin and Bivalirudin. Patients will be anticoagulated with a heparin bolus at the commencement of ECMO per standard of care, as there will be insufficient time to randomize these frequently emergent patients. Consent for the study will be obtained from a legally authorized representative Prior to starting a continuous infusion of maintenance anticoagulation, patients will be randomized to bivalirudin or heparin. Outcome measures are bleeding, thrombosis, development of Heparin Induced thrombocytopenia, number of cross-overs between the two research arms, circuit failures, decannulation, deaths and discharges from hospital.
Interventions
Treatment arms and agents.
DRUG
Bivalirudin Injection [Angiomax]
Intravenous Bivalirudin titrated to Activated Clotting Time (ACT) levels
Timeline
From registration to results.
First posted
Oct 16, 2018
Study start
Apr 2021
Primary completion
Jun 2021
Study completion
Jun 2021
Results posted
Not reported
Registry updated
Jan 19, 2021
Outcomes
What the study measures.
Primary outcomes
Number of heparin-induced thrombocytopenia (HIT) events
Time frame · 30 days
This will be assessed by serum platelet factor 4 antibody level
Number of Cross-overs between arms
Time frame · 30 days
This will be assessed by number of cross over of patients from one arm to the other anti-coagulation arm for any particular clinical reason. Crossover patients will remain in the study and we will continue to collect protocol driven data. These patients will be analyzed separately from those with no cross-over.
Number of circuit failures requiring a circuit exchange
Time frame · 30 days
Will be determined by total number of circuit exchanges needed in ECMO circuit due to thrombosis. Circuit exchanges may be done due to lack of adequate gas exchange or increased resistance pre and post oxygenator \>50mmHg, circuit thrombosis or failure requiring emergent decannulation
Thrombotic events
Time frame · 30 days
Collect number of thrombotic events, defined as any of the following events; embolic strokes, embolic end-organ ischemia, embolic ischemia to limbs, deep vein thrombosis or venous thromboembolism, Oxygenator effectiveness measured by resistance, Alveolar-arterial oxygen gradient and carbon dioxide elimination
Bleeding events
Time frame · 30 days
Will be assessed by the total number of one or more of the following: Chest tube output of blood, number of take-backs to operating room for bleeding, number of Hemorrhagic strokes, Gastrointestinal bleeding, Retroperitoneal hemorrhage, number of cessations of anticoagulation for refractory bleeding and any use of antifibrinolytics or factor VII
Renal failure
Time frame · 30 days
Defined as initiation of renal replacement therapy for kidney injury that develops on ECMO or increase in serum creatinine by more than 2 times its baseline or decrease in Glomerular Filtration Rate by more than 50% or urine output less than 0.3 mL/kg/hr. We will determine the number of patients with renal failure
Number of Transfusions
Time frame · 30 days
This will be assessed by any of the following: number of utilizations of packed red blood cells and utilization of fresh frozen plasma, utilization of platelets, utilization of cryoprecipitate, utilization of anti-thrombin III, utilization of factor VII, utilization of prothrombin complex concentrate
Number of emergent decannulations
Time frame · 30 days
This will be assessed by the number of times patient is separated from ECMO
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Adult patients on veno-arterial (VA) or veno-venous (VV)ECMO Exclusion Criteria: * Patient or surrogate decision makers cannot provide informed consent. * Patients who have intolerance to either heparin or bivalirudin * Patients who received any form of thrombolytic therapy within the past 30 days.
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Johns Hopkins University
Baltimore, Maryland, United States
Publications
Results and literature.
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Related PeptideStat pages
Put the record in context.
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